Objective: To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitor combined with chemotherapy as comparing with chemotherapy alone for the first-line treatment of advanced NSCLC (non-small lung cancer). Methods: RCTs (randomized controlled trials) on PD-1/PD-L1 inhibitor combined with chemotherapy compared with chemotherapy alone for the first-line treatment of advanced NSCLC were searched in the PubMed, Cochrane Library, EMbase, EBSCO, Chinese Biomedical Literature Database (CBM), Chinese Journal Full-text Database (CNKI), and Chinese Scientific Journal Full-text Database (VIP). RevMan 5.2 software was used for the Meta-analysis. Results: Six RCTs with 3 238 advanced NSCLC patients were included in this study. Meta-analysis showed that the combination therapy group was more effective than the chemotherapy alone group in OS (HR=0.86, 95%CI=0.79~ 0.94, P=0.0006) and PFS (HR=0.81, 95%CI=0.78~0.84, P<0.00001). The incidence of adverse reactions, such as thrombocytopenia of grade 1-5, vomiting, diarrhea, hypothyroidism, hyperthyroidism, rash, pneumonitis, colitis, hepatitis, dysgeusia, hepatitis of grade 3-5 and colitis, in combined treatment group were all higher than those in chemotherapy alone group, the differences were statistically significant (P<0.01 or P<0.05). Conclusions: Compared with chemotherapy alone, PD-1/PD-L1 inhibitor combined with chemotherapy can significantly improve the OS and PFS of patients with advanced NSCLC in the first-line treatment, while the overall incidence of adverse reactions is higher than chemotherapy.

[Abstract] Objective: To investigate the effects of antibiotics on the treatment efficacy of immune checkpoint inhibitors in NSCLC (non-small cell lung cancer) with Meta-analysis. Methods: Literatures regarding the effects of antibiotics on the treatment efficacy of immune checkpoint inhibitors in NSCLC were searched in Pubmed, Cochrane Library, Embase, EBSCO, Chinese Biomedical Literature Database(CBM) and Chinese Journal Full-text Database(CNKI). RevMan 5.3 software was used in this Meta-analysis. Results: Fourteen articles involving 2 505 NSCLC patients were included in this study. Meta-analysis showed that the application of antibiotics could significantly shorten the PFS (HR=1.14, 95%CI =1.04-1.26, P=0.005) and OS (HR=1.30, 95%CI =1.14-1.47, P<0.0001) of NSCLC patients treated with immune checkpoint inhibitors. Conclusion: Application of antibiotics before, concurrently or after immune checkpoint inhibitors in the treatment of NSCLC may significantly shorten PFS and OS, resulting in adverse effect on treatment efficacy.